INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL— 510(k) K140857

Name: FDA 510(k) clearance K140857
Creator: U.S. Food and Drug Administration
Published: 2014-04-25

Substantially Equivalent

Centers for Disease Control and Prevention

FDA 510(k) clearance K140857 for INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, Substantially Equivalent on 2014-04-25. Applicant: Centers for Disease Control and Prevention. Device class: 2.

Clearance details

Applicant: Centers for Disease Control and Prevention
Product code: Code OZE
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2014-04-03
Decision date: 2014-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.